Trial Outcomes & Findings for Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment (NCT NCT01277861)
NCT ID: NCT01277861
Last Updated: 2013-03-15
Results Overview
The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).
COMPLETED
PHASE4
100 participants
Induction of Anesthesia
2013-03-15
Participant Flow
Patients were recruited for the study in the preoperative period.
Participants were included based on inclusion/exclusion criteria. Participants were excluded if muscle relaxation was necessary for the surgery.
Participant milestones
| Measure |
FENTANYL
FENTANYL
|
SALINE
SALINE
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
|
Overall Study
COMPLETED
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
FENTANYL
FENTANYL
|
SALINE
SALINE
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
2
|
Baseline Characteristics
Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment
Baseline characteristics by cohort
| Measure |
FENTANYL
n=49 Participants
FENTANYL
|
SALINE
n=47 Participants
SALINE
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Body Mass Index
|
26.8 kg/m2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
26.8 kg/m2
STANDARD_DEVIATION 4.7 • n=7 Participants
|
26.8 kg/m2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Induction of AnesthesiaPopulation: Per protocol
The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).
Outcome measures
| Measure |
Fentanyl Pretreatment Group
n=49 Participants
Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
|
Saline Pretreatment Group
n=47 Participants
Saline 10 ml prior to induction of anesthesia.
|
|---|---|---|
|
Movement
|
8 Participants, number
|
24 Participants, number
|
SECONDARY outcome
Timeframe: Induction of AnesthesiaPopulation: Per protocol
Apnea defined as no breathing for at least 30 s.
Outcome measures
| Measure |
Fentanyl Pretreatment Group
n=49 Participants
Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
|
Saline Pretreatment Group
n=47 Participants
Saline 10 ml prior to induction of anesthesia.
|
|---|---|---|
|
Apnea
|
46 Participants, number
|
30 Participants, number
|
SECONDARY outcome
Timeframe: Intraoperative periodPopulation: Per protocol
Data include patients who coughed irrespective of the degree of coughing.
Outcome measures
| Measure |
Fentanyl Pretreatment Group
n=49 Participants
Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
|
Saline Pretreatment Group
n=47 Participants
Saline 10 ml prior to induction of anesthesia.
|
|---|---|---|
|
Coughing
|
1 Participants, number
|
6 Participants, number
|
Adverse Events
FENTANYL
SALINE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Girish P. Joshi, MD
University of Texas Southwestern Medical Center at Dallas
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place